Prothena Corporation plc, a biotechnology company, focuses on the discovery, development, and commercialization of immunotherapies for the treatment of diseases that involve protein misfolding and cell adhesion. Research and Development Pipeline The company’s research and development pipeline includes three therapeutic antibody programs in clinical development, including NEOD001 for the potential treatment of AL amyloidosis; PRX002, in collaboration with Roche, for the potential treatment of Parkinson’s disease and other related synucleinopathies; and PRX003 for the potential treatment of inflammatory diseases, including psoriasis. It also has a preclinical program for the potential treatment of transthyretin (TTR) amyloidosis (ATTR). Programs NEOD001 The company’s most advanced program is NEOD001, a humanized monoclonal antibody that specifically targets the circulating misfolded soluble light chain and deposited insoluble amyloid that accumulates in AL amyloidosis. NEOD001 received Fast Track designation from the U.S. Food and Drug Administration (the FDA) in December 2014. In addition, NEOD001 was granted orphan drug designation for the treatment of AL and AA amyloidosis by the FDA in 2012 and for the treatment of AL amyloidosis by the European Medicines Agency in 2013. The company is conducting The VITAL Amyloidosis Study, a Phase 3 clinical trial for its lead antibody, NEOD001, for the potential treatment of patients with AL amyloidosis; and PRONTO, a Phase 2b clinical trial for NEOD001 in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction. Concurrent with The VITAL Amyloidosis Study, the company has enrolled an additional 42 patients, with AL amyloidosis and selected persistent organ dysfunction, in an open-label expansion portion of the Phase 1/2 trial. PRX002 In 2013, the company entered into a license, development, and commercialization agreement (the ‘License Agreement’) with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (collectively, Roche) to develop and commercialize certain antibodies that target alpha-synuclein, including PRX002, which are referred to collectively as ‘Licensed Products’. Together with Roche, the company aims to develop PRX002 as a disease-modifying treatment for Parkinson’s disease and potentially other synucleinopathies. During 2014, together with Roche, the company advanced PRX002 into clinical development with the initiation of two Phase 1 studies. In addition, the company is enrolling patients with Parkinson’s disease in a Phase 1 multiple ascending dose study. The Phase 1 randomized, double-blind, placebo-controlled study of PRX002 is expected to enroll approximately 80 patients with Parkinson's disease at multiple centers across the U.S. and is designed to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRX002. In January 2016, the company added an additional dose level cohort to the ongoing Phase 1 multiple ascending dose trial of PRX002 in patients with Parkinson’s disease. License Agreement with Roche: Pursuant to the License Agreement, the company is collaborating with Roche to research and develop antibody products targeting alpha-synuclein. Roche is primarily responsible for developing, obtaining and maintaining regulatory approval for, and commercializing Licensed Products under the collaboration, including PRX002. Roche would also become responsible for the clinical and commercial manufacture and supply of Licensed Products within a defined time period following the effective date of the License Agreement. Under the License Agreement with Roche, the company granted to Roche an exclusive, worldwide license to develop, make, have made, use, sell, offer to sell, import and export the Licensed Products. PRX003 The company is developing PRX003, a monoclonal antibody targeting melanoma cell adhesion molecule (MCAM) for the potential treatment of inflammatory diseases including psoriasis. The company’s research in the area of cell adhesion has uncovered unique insights into MCAM function, allowing it to develop specific and novel antibodies that block MCAM’s VELCRO-like function and
prothena corp plc (PRTA:NASDAQ GS)
Upper George's Street
Dublin, A96 T927
Phone: 353 1 236 2500
Fax: 353 1 902 3510www.prothena.com
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